Protein and Ultrasound Indicators of Preterm Birth

NCT01412931 | Completed DMC

• 1 other identifier: 11-0570
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks). In this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term. The investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor. The investigators will collect the placental tissue after the baby is born (this is normally discarded). This study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Changes in Serial Elastography Measurements

  Serial elastography measurements will enable us to quantify changes in tissue modulus and structure longitudinally through normal, term pregnancy.

  Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).

Secondary Outcomes (3)

• Changes in Biomechanical and biochemical analyses of the chorioamnion

  Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).

• Correlation of Protein and biochemical analysis of the cervicovaginal fluid (CVF)

  Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).

• Stratification of Ultrasound parameters, chorioamnion biomechanical and biochemical properties, and CVF proteins .

  Groups a and b, ultrasound imaging and CVF collection will occur no more than four times with one week spacing between assessments. Group "d" will be assessed more frequently (up to 1× per day).

Study Arms (3)

1) Pregnant women with a single intrauterine pregnancy

50 women with uncomplicated pregnancies and no history of preterm birth.

2) Pregnant women with a single intrauterine pregnancy

50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM).

3) Pregnant women with a single intrauterine pregnancy

20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth.

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with a single intrauterine pregnancy with good gestational age dating, and live fetus with no indications for preterm delivery will be enrolled. Three groups of subjects will be recruited: a) 50 women with uncomplicated pregnancies and no history of preterm birth, b) 50 multiparous women with history of spontaneous preterm labor or preterm premature rupture of membranes (PPROM) c) 20 women evaluated on the labor and delivery unit because they are deemed to be at high risk for preterm birth. Pregnant women of all races and ethnicities will be recruited into the study.

You may qualify if:

• Single live intrauterine pregnancy
• Good gestational age dating

You may not qualify if:

• History of prior cervical procedure such as LEEP, CKC, or cryotherapy
• Maternal or fetal indication for preterm delivery
• Cerclage in place

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervicovaginal fluid and placental membranes will be retained for study.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Virginia Ferguson, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

US (1)